ISPE CEUs: 1.3
Type: Classroom Training Course
This course is also available as an online training course, Basic Principles of Computerized Systems Compliance course.
This course has been updated to include the new revised EU GMP Annex 11, and an overview of 21 CFR Part 11.
This fundamental course introduces participants to regulatory requirements for computerized systems in the pharmaceutical industry and explores tried, tested, and internationally recognized methods of meeting those requirements. GAMP guidance provides a pragmatic and effective framework for achieving computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner.
The course does not aim to cover detailed and highly technical aspects of software and hardware engineering, but rather gives the principles and an overview of the overall computer systems compliance process, including a scaleable and efficient system lifecycle, Quality Risk Management applying ICH Q9, updated GAMP categories, supplier assessment, and the selection of appropriate specification and verification activities.
Immediately apply the course learning objectives using the complimentary copy of the GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems Guide.
This course was developed by members of the ISPE GAMP Community of Practice. GAMP was established by industry leaders to interpret and improve the understanding of regulations governing the use of computerized systems in pharmaceutical manufacturing.
This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).
SAVE hundreds of dollars on training by joining ISPE! Join now »
This course is not currently scheduled, but may be offered at your company site.
Please contact ISPE for more information.
To qualify, all registrant information must be submitted at the same time; only ONE payment to cover all registrations will be accepted. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105.
Know Before You Go: Process Validation Conferences
Friday, 21 Oct 2016 12.10
Chairman’s Chatter: Collaboration
Thursday, 20 Oct 2016 14.10
Moving to Single-Use Continuous Manufacturing
Wednesday, 19 Oct 2016 12.10
This course can be offered at your company site in its current format or customized to meet the needs of your organization.